Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer

University of Michigan45 enrolled

Overview

In order to determine the acceptability of a breast cancer-specific cognitive behavioral therapy intervention, as well as to obtain preliminary data to assess efficacy in managing symptoms, the investigators will ask 45 breast cancer survivors with moderate insomnia, fatigue, and/or pain to use the investigators' internet-based intervention for 8 weeks and to complete patient-reported outcomes assessments before and after the 8 week intervention.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer Fatigue Insomnia Pain

Interventions

PROSPECT is an internet-based exercise and behavioral symptom management program developed for patients who experience long-term side effects from cancer treatment. The cancer-specific symptom management intervention is intended as a self-management adjunct to improve cancer- and treatment-related symptoms through non-pharmacologic approaches.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female * Stage 0-III invasive carcinoma of the breast * Surgical resection and axillary assessment, radiation therapy, and/or chemotherapy, as indicated, completed at least 3 months prior to enrollment. * Concomitant trastuzumab and anti-endocrine therapies are permitted. If taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment. * Must report at least one of the following: 1. Fatigue in the week prior to enrollment at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired) 2. Insomnia in the week prior to enrollment 3. Pain in the week prior to enrollment at least 4 on a 10 point scale (with 0 = no pain and 10 = extremely severe pain) * Has access to and is able to operate a computer with internet access. * Able to read and understand English. * Willing and able to sign an informed consent document. Exclusion Criteria: \- Diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep

Outcomes

Primary Outcomes

Improvement in patient-reported symptom with use of PROSPECT for 8 weeks

To obtain preliminary data about the efficacy of the intervention in this patient population. The investigators will assess change in the participant's primary reported symptom (pain, insomnia, or fatigue) with 8 weeks of the intervention.

Time frame: 8 weeks

Secondary Outcomes

Acceptability of the PROSPECT intervention based on patient self-report

To obtain preliminary data about the acceptability and usability of the intervention in this patient population.